 (NaturalNews) The U.S. Food and Drug Administration announced yesterday that it has formally agreed to expand the off-label use of Genentech's Herceptin breast cancer drug to include patients with early-stage breast cancer who have undergone surgery.
The FDA's decision to expand Herceptin prescribing practices was expected in August, but the agency requested more information prior to its decision. However, according to Citigroup analysts, doctors across the country were already extensively prescribing Herceptin to early-stage breast cancer patients before the FDA gave approval.
Herceptin first entered the market in 1998 as a treatment for the 25 to 30 percent of breast cancer patients whose tumors generate a protein called HER-2. The drug was recommended for patients whose cancer had spread beyond the breast.
After Genentech announced last year that it had conducted a trial yielding positive results for the use of Herceptin in combination with chemotherapy in early-stage cancer patients, doctors began writing off-label prescriptions for the drug in such patients, prior to FDA approval.
Off-label prescribing is the practice of a physician prescribing a drug to treat a condition for which the FDA has not approved the drug. Essentially, once a drug is approved to treat one condition, it can then be legally prescribed to treat any other condition, despite lack of safety or effectiveness testing for treating unapproved conditions.
In the first nine months of 2006, U.S. sales of Herceptin increased by 84 percent from the same period in 2005, to $912 million. Citigroup says the FDA's approval of off-label prescriptions is unlikely to increase sales further, since doctors had already been prescribing the drug for early-stage patients.
Consumer health advocate Mike Adams, author of a critical cartoon on Herceptin, said, "The FDA's wink-and-nod tolerance of off-label prescribing makes a mockery of the entire drug approval process.
"Today's laws say that doctors can prescribe any drug for literally any condition, regardless of whether it has ever been approved or even tested for such conditions," he said. "To call this 'evidence-based medicine' is downright laughable."
A study appearing in the August issue of the Journal of Clinical Oncology found that Herceptin caused heart damage in 28 percent of its users.
###
Related Articles
• Mammograms cause breast cancer (and other cancer facts you probably never knew)
• Sunlight emerging as proven treatment for breast cancer, prostate cancer and other cancers
• Vitamin D Recommendation Missing From Breast Cancer Task Force Report on Black Women
• Breast Cancer Industry A Scam? Support Education, Not Medication
• Education Not Medication -- a women's health program by Mike Adams
 |
Additional Resources:
breast cancer
Herceptin
off-label prescribing
|
Take Action: Support NaturalNews.com
 Email this article to a friend
 Share this article on: NewsVine | digg | del.icio.us
Permalink to this article: http://www.NaturalNews.com/021109.html
Reprinting this article: Non-commercial OK, cite NaturalNews.com with clickable link.
|
 |
 |
Receive our Natural Health Newsletter for FREE
 Subscribe now (it's free!) to win. We randomly choose a subscriber each month to send $100 in eco-home products or a RealGoods.com gift certificate (our choice). Plus, you'll receive FREE news, articles and action alerts from NaturalNews.com editors and join over 800,000 monthly readers who report extraordinary health improvements after becoming a subscriber!
- Receive breaking news alerts on natural health solutions, renewable energy, the environment, global warming and more.
- Receive a free instant download of our $29 Secret Sources guide that reveals top sources for little-known health and diet solutions.
|
|
 |
 |
Recommended Special Report:
 Seven Words that can Change the World
by Joseph R. Simonetta
Read this special report now...
"Seven Words That Can Change the World reveals the astonishing, simple truths that have the power to forever transform our world for the better while freeing our minds from the enslavement of limiting beliefs. This is not a text for the simple-minded; it is a guiding philosophy for the mindful, intelligent few who are wise enough to seek out -- and recognize -- the higher simplicities of truly purposeful living." - Mike Adams, the Health Ranger, editor of NaturalNews.com
|
More on NaturalNews.com:
• Streaming Health Ranger Videos
• CounterThink Cartoons
• FREE Special Reports
• Podcasts
|
 |
|
Printable Version
